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WO2004060351A3 - Pharmaceutical formulation with an insoluble active agent for pulmonary administration - Google Patents

Pharmaceutical formulation with an insoluble active agent for pulmonary administration Download PDF

Info

Publication number
WO2004060351A3
WO2004060351A3 PCT/US2003/041703 US0341703W WO2004060351A3 WO 2004060351 A3 WO2004060351 A3 WO 2004060351A3 US 0341703 W US0341703 W US 0341703W WO 2004060351 A3 WO2004060351 A3 WO 2004060351A3
Authority
WO
WIPO (PCT)
Prior art keywords
active agent
pharmaceutical formulation
pulmonary administration
insoluble active
particulates
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2003/041703
Other languages
French (fr)
Other versions
WO2004060351A2 (en
Inventor
Thomas E Tarara
Jeffry G Weers
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nektar Therapeutics
Original Assignee
Nektar Therapeutics
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32713146&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2004060351(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to AU2003300137A priority Critical patent/AU2003300137A1/en
Application filed by Nektar Therapeutics filed Critical Nektar Therapeutics
Priority to EP03800395.0A priority patent/EP1589947B2/en
Priority to JP2004564917A priority patent/JP2006513236A/en
Priority to ES03800395T priority patent/ES2589578T5/en
Priority to EA200501001A priority patent/EA200501001A1/en
Priority to HU0500846A priority patent/HUP0500846A3/en
Priority to CA2511523A priority patent/CA2511523C/en
Priority to MXPA05007158A priority patent/MXPA05007158A/en
Priority to BR0317810-2A priority patent/BR0317810A/en
Publication of WO2004060351A2 publication Critical patent/WO2004060351A2/en
Publication of WO2004060351A3 publication Critical patent/WO2004060351A3/en
Priority to NO20053076A priority patent/NO20053076L/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Dispersion Chemistry (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

A pharmaceutical formulation for pulmonary administration comprises particulates comprising an active agent particle in a lipid matrix, the active agent having a solubility in water of less than 1.0 mg/ml. In one version, at least 90% of the active agent particles in the pharmaceutical formulation have a geometric diameter less than 3 µm. In another version, the insoluble active agent comprises amphotericin B. The particulates may have a size and shape to allow the aerosolized pharmaceutical formulation to be delivered to the deep lung.
PCT/US2003/041703 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration Ceased WO2004060351A2 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
CA2511523A CA2511523C (en) 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration
HU0500846A HUP0500846A3 (en) 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration
EP03800395.0A EP1589947B2 (en) 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration
JP2004564917A JP2006513236A (en) 2002-12-31 2003-12-31 Pharmaceutical formulations with insoluble active substances
ES03800395T ES2589578T5 (en) 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration
EA200501001A EA200501001A1 (en) 2002-12-31 2003-12-31 PHARMACEUTICAL COMPOSITION WITH INSOLVABLE ACTIVE AGENT
MXPA05007158A MXPA05007158A (en) 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration.
AU2003300137A AU2003300137A1 (en) 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration
BR0317810-2A BR0317810A (en) 2002-12-31 2003-12-31 Pharmaceutical formulation and method of manufacturing the same
NO20053076A NO20053076L (en) 2002-12-31 2005-06-23 Pharmaceutical formulation with an insoluble active compound.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US43721002P 2002-12-31 2002-12-31
US60/437,210 2002-12-31

Publications (2)

Publication Number Publication Date
WO2004060351A2 WO2004060351A2 (en) 2004-07-22
WO2004060351A3 true WO2004060351A3 (en) 2004-09-30

Family

ID=32713146

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/041703 Ceased WO2004060351A2 (en) 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration

Country Status (18)

Country Link
US (1) US20040156792A1 (en)
EP (1) EP1589947B2 (en)
JP (1) JP2006513236A (en)
KR (1) KR20050095838A (en)
CN (1) CN1741789A (en)
AU (1) AU2003300137A1 (en)
BR (1) BR0317810A (en)
CA (1) CA2511523C (en)
EA (1) EA200501001A1 (en)
ES (1) ES2589578T5 (en)
HU (1) HUP0500846A3 (en)
MX (1) MXPA05007158A (en)
NO (1) NO20053076L (en)
PL (1) PL378270A1 (en)
PT (1) PT1589947T (en)
TR (1) TR200502522T2 (en)
WO (1) WO2004060351A2 (en)
ZA (1) ZA200505155B (en)

Cited By (3)

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US9084976B2 (en) 2010-09-03 2015-07-21 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9084944B2 (en) 2010-09-03 2015-07-21 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9248584B2 (en) 2010-09-24 2016-02-02 Bend Research, Inc. High-temperature spray drying process and apparatus

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US20060165606A1 (en) * 1997-09-29 2006-07-27 Nektar Therapeutics Pulmonary delivery particles comprising water insoluble or crystalline active agents
US6565885B1 (en) * 1997-09-29 2003-05-20 Inhale Therapeutic Systems, Inc. Methods of spray drying pharmaceutical compositions
US7871598B1 (en) 2000-05-10 2011-01-18 Novartis Ag Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use
TWI290473B (en) 2000-05-10 2007-12-01 Alliance Pharma Phospholipid-based powders for drug delivery
US8404217B2 (en) 2000-05-10 2013-03-26 Novartis Ag Formulation for pulmonary administration of antifungal agents, and associated methods of manufacture and use
DK1458360T3 (en) 2001-12-19 2011-08-29 Novartis Ag Pulmonary release of aminoglycosides
WO2004060903A2 (en) * 2002-12-31 2004-07-22 Nektar Therapeutics Aerosolizable pharmaceutical formulation for fungal infection therapy
KR101511196B1 (en) 2003-05-28 2015-04-10 노바르티스 아게 Spray drying of an alcoholic aqueous solution for the manufacture of a water-insoluble active agent microparticle with a partial or complete amino acid and/or phospholipid coat
US8513204B2 (en) * 2004-06-21 2013-08-20 Novartis Ag Compositions comprising amphotericin B, mehods and systems
US9061027B2 (en) 2004-08-27 2015-06-23 Board Of Regents, The University Of Texas System Enhanced delivery of drug compositions to treat life threatening infections
WO2007041090A2 (en) * 2005-09-29 2007-04-12 Nektar Therapeutics Receptacles and kits, such as for dry powder packaging
ITMI20051999A1 (en) * 2005-10-21 2007-04-22 Eratech S R L INHALATION FORMULATIONS OF DRUGS IN DRY POWDER FOR ADMINISTRATION AS SUCH OR WITH NEBULIZER AND EQUIPPED WITH HIGH EROGABILITY RESPIRABILITY AND STABILITY
US20120128728A1 (en) * 2005-12-28 2012-05-24 Novartis Pharma Ag Compositions Comprising Amphotericin B
CN101389348A (en) * 2006-02-22 2009-03-18 曼金德公司 Method for improving the pharmaceutical properties of microparticles comprising diketopiperazines and an active agent
DE102006053375A1 (en) * 2006-11-10 2008-05-15 Boehringer Ingelheim Pharma Gmbh & Co. Kg Process for mixing powders
NO2170279T3 (en) * 2007-07-31 2018-05-26
EP2050437A1 (en) * 2007-10-15 2009-04-22 Laboratoires SMB Improved pharmaceutical dry powder compositions for inhalation.
PL220269B1 (en) 2008-04-21 2015-09-30 Przedsiębiorstwo Produkcji Farmaceutycznej Hasco Lek Spółka Akcyjna Composite carrier of powdered medicines, method of production the medicine carrier and equipment for production of particles of composite carrier
RU2497524C2 (en) * 2008-05-15 2013-11-10 Новартис Аг Intrapulmonary administration of fuoroquinolone
ES3003038T3 (en) 2009-03-18 2025-03-10 Incarda Therapeutics Inc Unit doses, aerosols, kits, and methods for treating heart conditions by pulmonary administration
ES2873502T3 (en) 2009-03-27 2021-11-03 Bend Res Inc Spray drying process
GB0908129D0 (en) * 2009-05-12 2009-06-24 Innovata Ltd Composition
TR200904500A2 (en) 2009-06-10 2009-10-21 Öner Levent Methods and pharmaceutical formulations for the preparation of ezetimibe nanocrystals.
AU2011320159B2 (en) * 2010-10-29 2016-12-22 Western University Of Health Sciences Ternary mixture formulations
JOP20120023B1 (en) 2011-02-04 2022-03-14 Novartis Ag Dry powder formulations of particles that contain two or more active ingredients for treating obstructive or inflammatory airways diseases
JP2017505325A (en) * 2014-02-03 2017-02-16 ザ ボード オブ トラスティーズ オブ ザ リーランド スタンフォード ジュニア ユニバーシティ Formulation for microparticle delivery of zinc protoporphyrin
EP3212169B1 (en) 2014-10-31 2021-01-13 Bend Research, Inc. Process for forming active domains dispersed in a matrix
CN104587457B (en) * 2015-01-13 2017-03-22 广东海大畜牧兽医研究院有限公司 Method for preparing nanoparticle vaccine by utilizing slightly soluble or insoluble protein/polypeptide antigens
SG11201805204WA (en) * 2015-12-24 2018-07-30 Philip Morris Products Sa Nicotine particle capsule
CN114847965A (en) 2016-02-01 2022-08-05 英凯达治疗公司 Electronic monitoring combined with inhaled pharmacological therapy to manage arrhythmias
JP2020519628A (en) 2017-05-10 2020-07-02 インカーダ セラピューティクス， インコーポレイテッド Unit doses, aerosols, kits and methods for treating cardiac conditions by pulmonary administration
CN117958505A (en) * 2017-06-28 2024-05-03 菲利普莫里斯生产公司 Container and system for use in an inhaler containing a powder system
EP3768378B1 (en) 2018-03-22 2025-08-06 InCarda Therapeutics, Inc. A novel method to slow ventricular rate
GB201817860D0 (en) 2018-11-01 2018-12-19 Nicoventures Trading Ltd Aerosolised formulation
GB201817865D0 (en) * 2018-11-01 2018-12-19 Nicoventures Trading Ltd Aerosolisable formulation
US11007185B2 (en) 2019-08-01 2021-05-18 Incarda Therapeutics, Inc. Antiarrhythmic formulation
EP4496588A1 (en) 2022-03-21 2025-01-29 The Board Of Trustees Of The University Of Illinois Ion channel prosthetic compositions comprising lipid-coated crystals of amphotericin b

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9084976B2 (en) 2010-09-03 2015-07-21 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9084944B2 (en) 2010-09-03 2015-07-21 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9205345B2 (en) 2010-09-03 2015-12-08 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9358478B2 (en) 2010-09-03 2016-06-07 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9248584B2 (en) 2010-09-24 2016-02-02 Bend Research, Inc. High-temperature spray drying process and apparatus

Also Published As

Publication number Publication date
BR0317810A (en) 2005-11-29
CA2511523A1 (en) 2004-07-22
CA2511523C (en) 2013-10-15
HUP0500846A3 (en) 2008-10-28
NO20053076L (en) 2005-09-13
WO2004060351A2 (en) 2004-07-22
MXPA05007158A (en) 2005-09-21
ES2589578T5 (en) 2019-07-23
EP1589947B2 (en) 2019-01-30
JP2006513236A (en) 2006-04-20
US20040156792A1 (en) 2004-08-12
EA200501001A1 (en) 2005-12-29
TR200502522T2 (en) 2005-09-21
ES2589578T3 (en) 2016-11-15
PT1589947T (en) 2016-09-05
ZA200505155B (en) 2006-04-26
NO20053076D0 (en) 2005-06-23
AU2003300137A1 (en) 2004-07-29
PL378270A1 (en) 2006-03-20
EP1589947A2 (en) 2005-11-02
EP1589947B1 (en) 2016-06-15
KR20050095838A (en) 2005-10-04
EP1589947B8 (en) 2016-08-24
HUP0500846A2 (en) 2008-05-28
CN1741789A (en) 2006-03-01

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